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Test Development and Validation 

Test Development and Validation
Test Development and Validation

Lisa Catalano

and Alice K. Tanner

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date: 19 May 2022

The process of developing a genetic test starts with an initial assessment of need and utility, followed by the development and validation of the chosen testing method. Several factors must be taken into account during test development, including existing technology, financial requirements, personnel resources, and market share. This chapter reviews the steps involved in the development and the validation/verification of clinical genetic testing. It discusses the factors that are addressed by clinical genetic testing laboratories during the design and implementation phases of test development. The role of the laboratory genetic counselor in this process is highlighted throughout.

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